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OpenTrials
Completed

NCT Number: NCT04539899

Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion

Given the current lack of satisfactory options for the management of IUD insertion pain, could the virtual reality headset be an innovative and effective tool? The objective is to compare the pain experienced during IUD insertion between a group of women wearing a virtual reality helmet and a group not wearing one.

Observational, prospective, randomized, open-label, monocentric study.

Completed

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Key information

Conditions

IUD

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rennes, Rennes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female adult
  • Who has benefited from contraceptive counseling
  • The choice of an IUD (hormonal or copper)
  • Having signed a written informed consent.
  • Affiliation to a social security scheme.

Exclusion criteria

  • Pre-existing dizzying sensations
  • Severe facial wounds
  • History of epilepsy
  • Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.

Treatment and study plan

VR+

Other

Use of a virtual reality helmet during IUD insertion

Primary outcomes

  1. NRS during IUD insertion

    Time frame: 20 minutes

    The assessment criterion used is the written self-report numerical scale (NRS) from 0 to 10 (0 = no pain, 10 = extremely painful)

Secondary outcomes

  1. Stress level difference with virtual reality

    Time frame: 20 minutes

    Difference of stress between experimental and control group using self-assessment anxiety scale specially designed for the study, where 0 = non stress and 10 = maximum of stress

  2. Satisfaction level difference with virtual reality

    Time frame: 20 minutes

    Difference of satisfaction between experimental and control group using self-assessment anxiety scale specially designed for the study, where 0 = not satisfied at all and 10 = totally satisfied

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion : REAVIST

Acronym: REAVIST

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 7, 2020
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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